Temporal Interference Neurostimulation and Addiction

Last updated: June 20, 2025
Sponsor: Indiana University
Overall Status: Terminated

Phase

N/A

Condition

Tobacco Use Disorder

Stimulant Use Disorder

Addictions

Treatment

Active TI-NDBS

Sham TI-NDBS

tDCS

Clinical Study ID

NCT04432064
1904451651
  • Ages 18-50
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This project aims to develop a line of research using new non-invasive neurostimulation technology to treat adults with opioid use disorders (OUDs). In the short term, the investigators aim to identify novel target brain regions for neurostimulation treatment and characterize their effects behaviorally and neurally. In the longer term, investigators aim to use these preliminary data to justify NIH sponsored clinical trials to apply transcranial direct current stimulation and non-invasive deep brain stimulation to these areas to partially or completely disrupt addiction.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Must be between the ages of 18 and 50, must have at least 6th grade education, andthe ability to speak and read English, must smoke at least 3/4 of a pack ofcigarettes per day, must have phone with internet access.

Exclusion

Exclusion Criteria:

  • if they are on psychotropic medications for ADHD, other mental illness or medicationfor cancer, epilepsy (i.e. individuals with any history of seizure disorder),migraines, or other neurological syndromes, or AIDs (which can cause cognitivedeficits (Watkins & Treisman, 2015), history of head trauma, history of cognitiveimpairments, metal implants in the head or under the scalp, personal experiencesconsistent with symptoms of psychosis (i.e. mind or body being secretly controlled,special powers, seeing or hearing things that aren't really there).

  • Subjects will be excluded if they do not meet fMRI safety screening criteria (i.e.metal implants in their body, tattoo on head or neck, permanent jewelry, etc.) or ifa participant uses an IUD for birth control they will be excluded unless the subjectcan document the model of the IUD and we can verify its safety for the MRIenvironment. Pregnancy should be self-reported, and a pregnancy test will not beadministered. Participants must also weigh less than 440 lbs.

  • History of holes bored into skull or known fissures in cranial bones

  • Presence of pacemakers

Study Design

Total Participants: 10
Treatment Group(s): 3
Primary Treatment: Active TI-NDBS
Phase:
Study Start date:
July 06, 2020
Estimated Completion Date:
April 21, 2022

Study Description

The investigators hypothesize that temporal interference non-invasive deep brain stimulation (TI-NDBS) will be well tolerated and effective at manipulating brain activity and reducing drug cravings. The investigators will investigate whether stimulation with a mild current from temporal interference non-invasive deep brain stimulation (TI-NDBS) to the Anterior Cingulate Cortex (ACC), the anterior insula (AI), or the nucleus accumbens (NAcc) will reduce nicotine craving and seeking. The TI-NDBS is similar to the traditional transcranial direct current stimulation (tDCS), a method approved for use in a number of other studies. Other studies have shown there have been some effects of reducing craving with tDCS, however, tDCS cannot stimulate structures such as the ACC very effectively because tDCS cannot stimulate deeper brain regions. Thus, the Specific Aim ultimately will compare TI-NDBS with tDCS and sham stimulation. The study is broken up into four phases. The first two will involve device feasibility and identifying the best locations for the electrodes to be placed. In the third phase, the investigators will compare TI-NDBS with sham stimulation. In the fourth phase, the investigators will compare TI-NDBS with sham stimulation and with tDCS.

Connect with a study center

  • Indiana University

    Bloomington, Indiana 47403
    United States

    Site Not Available

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